Cleared Traditional

K931299 - HISTOFREEZER

K931299 is an FDA 510(k) clearance for HISTOFREEZER, manufactured by Solarcare Technologies Corp,Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K931299 · Solarcare Technologies Corp,Inc. · General & Plastic Surgery device
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Aug 1993
Decision
149d
Days
Class 2
Risk

K931299 is an FDA 510(k) clearance for the HISTOFREEZER. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Solarcare Technologies Corp,Inc. (Bethlehem, US). The FDA issued a Cleared decision on August 11, 1993 after a review of 149 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4350 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Solarcare Technologies Corp,Inc. devices

FDA 510(k) Submission Details - K931299

510(k) Number K931299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1993
Decision Date August 11, 1993
Days to Decision 149 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 115d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEH Device Classification - Class 2, Special Controls

Product Code GEH Unit, Cryosurgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEH Unit, Cryosurgical, Accessories

All 214
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K931299.
CANDELA CRYOSYSTEM CS-5
K953294 · Candela Laser Corp. · Oct 1995
ERBOKRYO CA CRYOSURGICAL SYSTEM
K934261 · Erbe Elektromedizin GmbH · Apr 1994
WALLACH ULTRA FREEZE
K935010 · Wallach Surgical Devices, Inc. · Feb 1994
HISTOFREEZER
K924114 · Solarcare Technologies Corp,Inc. · Feb 1993
HISTOFREEZER
K911420 · Solarcare Technologies Corp,Inc. · Jun 1991
WALLACH COLD SOAKER
K910491 · Wallach Surgical Devices, Inc. · May 1991